Promethazine Hydrochloride Promethazine Hydrochloride 25 MG Oral Tablet

INDICATIONS AND USAGE Promethazine Hydrochloride Tablets are useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled. Preoperative, postoperative and obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients.

Amneal Pharmaceuticals

FDA Reported Adverse Reactions
`[1] dyspnoea` `[2] drug ineffective` `[3] fatigue` `[4] nausea` `[5] off label use` `[6] pain` `[7] wrong technique in product usage process` `[8] headache` `[9] no adverse event` `[10] death`

7 years ago

ROUND WHITE AN 521

HOW SUPPLIED

PROMETHAZINE HYDROCHLORIDE Tablets, USP for oral administration are available as: 12.5 mg: white to off-white, biconvex, round uncoated tablets, debossed with “AN” and bisect on one side and “745” on the other side are supplied as: Bottles of 100: NDC 65162-745-10 Bottles of 500: NDC 65162-745-50 25 mg: white to off-white, flat-faced, beveled edge, round, uncoated tablets, debossed with “AN” above “521” with single line bisect separating them on one side and plain on the other side are supplied as: Bottles of 100: NDC 65162-521-10 Bottles of 500: NDC 65162-521-50 Bottles of 1000: NDC 65162-521-11 50 mg: pink color, biconvex, round tablets, debossed with “AN” above “522” on one side and plain on the other side are supplied as: Bottles of 100: NDC 65162-522-10 Bottles of 500: NDC 65162-522-50 Store at 20º to 25°C (68° to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 10-2015-00

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